|Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim||Powder for Suspension||128mg + 1280mg + 360mg||1000.2625|
PHARMACEUTICAL FORM AND PRESENTATION: Granules for oral suspension. Off-white or light yellow granules in a 60ml bottle with measuring cup. Each 60ml bottle contains Dihydroartemisinin 128mg, Piperequine phosphate 1280mg, Trimethoprim 360mg.
QUALITATIVE AND QUANTITATIVE COPOSITION: Each 5ml of reconstituted suspension contains: Dihydroartemisinin 10.7mg, Piperaquine phosphate 107mg, Trimethoprim 30mg. Excipients: lactose, xanthan gum, aerosol, ethanol, sqf 1 bottle.
THERAPEUTIC INDICATION: This medicine is a compound antimalarial drug recommended for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria, in particular, in the case of resistance to other antimalarials.
DOSAGE AND ADMINISTRATION: For children and infants. Add proper water until the volume of bottle (60ml) to reconstitute oral suspension. Shake well before use. Recap the bottle immediately after use. The treatment duration is 2 days. Dosage should be adapted according to weight.
CONTRAINDICATIONS: Hypersensitivity to one of the Excipients, pregnancy, severe liver or renal impairment, hematopathy (e.g. leucopenia or thrombocytopenia).
ADVERSE REACTIONS: Main adverse reactions of Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim are:
- Digestive tract: nausea, vomiting, impaired appetite, abdominal pain, diarrhea and salivation.
- Nerve system: dizziness, headache, tinnitus, asthenia, hyposomnia.
- Allergic reaction: skin itch and eruption.
- Laboratory abnormalities: transient peripheral erythropenia, transient increase of SGPT and SGOT, leucopenia and thrombocytopenia.
OVERDOSAGE: In the event of overdose, the patient should be treated symptomatically and supportive measures should be instituted as required, such as gastric lavage, infusion of glucose and sodium solutions.
Pharmacodynamic properties: This Powder for Suspension is a compound antimalarial drug containing dihydroartemisinin, piperaquine phosphate and trimethoprim.
- Dihydroartemisinin has a strong gametocidal action against plasmodium agamic body.
- Piperaquine phosphate antimalarial action is similar to that of chloroquine; after oral administration, piperaquine is absorbed and is stored in liver, then is slowly released into blood, with a long-lasting action and is therefore used for prevention and treatment of malaria.
- Trimethoprim has the function of inhibiting dihydrofolate reductase. It combines with the dihydrofolate reductase of plasmodium interfering with the synthesis of purine so as to inhibit the growth of plasmodium.
Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim has a rapid and powerful plasma schizonticide with rapid symptom control and effectiveness for multi-drug resistant P.falciparum malaria, and remarkable inhibitory effect of falciparum gametocyte thus minimizing the malaria transmissibility. Pharmacodynamic studies on mice and monkeys demonstrated that the three ingredients of Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim have obvious synergistic effect. In the studies of 975 cases of P.falciparum malaria and 171 cases of P.vivax malaria in multi-drug resistant falciparum malaria endemic areas, with follow-up for 28 days, the cure rate of P.falciparum malaria was 96.9%, with recrudescence rate of 3.1%; the recurrence rate of P.vivax malaria was 2.7%. The fever clearance time was 16-25 hours and the parasite clearance time was 24-56 hours.
Pharmacokinetic properties: After oral administration, Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim oral suspension is absorbed by gas-trointestinal tract, where dihydroartemisinin is well absorbed with rapid effect, wide distribution and rapid excretion and metabolism. In 30 minutes after oral administration, piperaquine phosphate is detected. While trimethoprim is rapidly and completely absorbed, blood peak concentration is reached in 1-2 hours. After absorption, Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim for suspension is mainly distributed in liver, kidney, intestine, blood and body fluids. It is mainly excreted via kidney and intestinal tract. As Artemisinin derivatives are antimalarial drug with short half-life and rapid effect, and can kill plasmodium rapidly, in combination with piperaquine phosphate that has long half-life, together with the synergistic effect of trimethoprim which has the fuction of inhibiting dihydrofolate reductase. Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim for suspension is effective in inhibiting growth of plasmodium and reducing the relapse rate of malaria.
Shelf life: 24 months. Special precaution for storage: Protect from light in tight containers and keep in a dry and cool place.
Mercator's Other popular Antimalarial products according to the WHO guidelines include:
1. Arteether Injection
2 Artemether + Lumefantrine Powder for Suspension
3. Artemether + Lumefantrine Tablets
4. Artemether Injection
5. Artemisinin + Piperaquine Tablets
6. Artesunate + Amodiaquine Tablets
7. Artesunate + Mefloquine Tablets
8. Artesunate + Sulfadoxine + Pyrimethamine Tablets
9. Chloroquine Phosphate Injection
10. Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim Powder for Suspension
11. Dihydroartemisinin + Piperaquine Phosphate + Trimethoprim Tablets
12. Dihydroartemisinin + Piperaquine Phosphate Powder for Suspension
13 Dihydroartemisinin + Piperaquine Phosphate Tablets
14. Quinine Dihydrochloride Injection
15. Sulfadoxine + Pyrimethamine Tablets